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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Hemi-, Ulnar
510(k) Number K082839
Device Name DISTAL RADIO-ULNAR JOINT IMPLANT
Applicant
Aptis Medical, LLC
3602 Glenview Ave.
Glenview,  KY  40025
Applicant Contact BRYAN BABB
Correspondent
Aptis Medical, LLC
3602 Glenview Ave.
Glenview,  KY  40025
Correspondent Contact BRYAN BABB
Regulation Number888.3810
Classification Product Code
KXE  
Date Received09/26/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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